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Dose-response of Talus Mobilizations (ANKLE_ROM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360512
Recruitment Status : Terminated (Suspended due to the covid-19 pandemic.)
First Posted : April 24, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
David Hernández, University of Valencia

Brief Summary:
Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).

Condition or disease Intervention/treatment Phase
Aging Problems Procedure: Posteriorization of the talus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dose-response of Posterior Talus Mobilizations on Ankle Range of Motion and Overall Mobility in Older Adults
Actual Study Start Date : May 15, 2020
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : September 14, 2020

Arm Intervention/treatment
Experimental: One session
One session of talus posteriorization
Procedure: Posteriorization of the talus
Three sets of a 30-s grade IV mobilization

Experimental: Two sessions
Two sessions of talus posteriorization
Procedure: Posteriorization of the talus
Three sets of a 30-s grade IV mobilization

Experimental: Three sessions
Three sessions of talus posteriorization
Procedure: Posteriorization of the talus
Three sets of a 30-s grade IV mobilization

Experimental: Four sessions
Four sessions of talus posteriorization
Procedure: Posteriorization of the talus
Three sets of a 30-s grade IV mobilization




Primary Outcome Measures :
  1. Treatment dose [ Time Frame: Change from baseline to end of intervention (2 weeks) ]
    Number of sessions of experimental intervention needed to induce a clinically important gain in ankle mobility after the intervention. A baseline progression over 4.6º in the Lunge test will be considered clinically important (Powden, 2015), so that the number of sessions will be established when this threshold is exceeded (see secondary outcome) .


Secondary Outcome Measures :
  1. The Lunge test [ Time Frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks) ]
    Weight bearing ankle dorsiflexion range of motion. This test will measure the maximum tilt of the tibia that a subject can perform while standing and bearing the weight on the limb without lifting the heel from the floor. A Baseline® Digital Inclinometer (Fabrication Enterprises Inc) will be used to assessed this outcome. Values below 35º indicate limited mobility. A baseline progression over 4.6º will be considered clinically important (Powden, 2015). This mobility gain will be used to determine the dose-response relationship: number of sessions of talus mobilizations needed to induce a clinically important gain in ankle mobility after the intervention (see primary outcome measure)

  2. Active ankle range of motion [ Time Frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks) ]
    Non-weight bearing active ankle range of motion in the sagittal plane: dorsi to plantarflexion full range of motion. This will be assessed with a telescopic goniometer, with the participant laying in supine with a wedge under the knees to eliminate the tension of the gastrocnemius muscles. Values below 59º indicate limited ankle mobility. The minimal detectable change for this measure has not been well established in literature. A baseline progression over 5.2º will be considered clinically important (Searle, 2018; Konor, 2012)

  3. Timed up and go test (TUG) [ Time Frame: Change from baseline, to end of intervention (2 weeks) and follow-up (10 weeks) ]
    A timed test used to assess overall mobility and dynamic balance, in which the time taken to get up from and arm-chair, walk three meters, turn around a cone and come back to sit again, is registered to estimate the functional mobility. We will consider times below 12 s as normal performances in the study populattion, and below 13,5 s as low risk of falling. A baseline change over 2.08 s will be considered clinically important (Donoghue, 2019)


Other Outcome Measures:
  1. Euro Quality of Life Five Dimensions (EQ-5D) [ Time Frame: Change from baseline, to follow-up (10 weeks) ]
    The descriptive system comprises five dimensions to assess health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community-dwelling older adults
  • Over 60 years
  • Limited ankle dorsiflexion range of motion

Exclusion Criteria:

  • Not willing to participate or signing a consent form
  • Lower limb injury in the three months prior to the study (ex. sprain)
  • Diagnosed condition that may influence mobility assessments (i.e. stroke)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360512


Locations
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Spain
Universidad de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia
Investigators
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Study Director: José-María Blasco, PT, PhD University of Valencia
Study Chair: David Hernández-Guillén, PT, PhD University of Valencia
Principal Investigator: Catalina Tolsada-Velasco, PT University of Valencia
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Responsible Party: David Hernández, PT, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT04360512    
Other Study ID Numbers: DHG05
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Hernández, University of Valencia:
ROM
Manual therapy
Dose-response
Mobilization
Ankle